US6322495B1 - Method for placing a feeding tube inside a gastro-intestinal tract - Google Patents

Abstract

An optical feeding tube includes an elongated sheath having a first lumen for delivering nutrients to a gastrointestinal tract and an imaging device disposed in a second lumen. The imaging device provides visualization of an area adjacent a distal end of the elongated sheath. The imaging device can be an optical fiber extending from a proximal end to a distal end of the elongated sheath. The optical feeding tube can also include a retention device. The method for placing the feeding tube involves passing the feeding tube through an opening in the abdominal wall and into a gastro-intestinal tract while observing a passageway ahead of the feeding tube.

Description

RELATED APPLICATIONS

This application is a divisional of U.S. Ser. No. 09/007,500, filed Jan. 15, 1998, now U.S. Pat. No. 5,989,231, the disclosure of which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

This invention relates to a feeding tube and, more particularly, to an improved feeding tube which allows visualization inside a gastrointestinal tract during the feeding tube placement or replacement.

BACKGROUND INFORMATION

Patients who are unable to take oral feedings can receive nutrients through a feeding tube by placing a distal end of the feeding tube in a patient's gastrointestinal tract and delivering nutrients to a proximal end of the feeding tube. Various procedural options exist for placing a feeding tube inside a patient.

One feeding tube placement method involves passing a nasoenteric feeding tube through a patient's mouth into his or her alimentary tract. This method, however, may not be suitable for certain patients, such as those with an obstruction in the alimentary tract at or beyond the pylorus, those with severe gastroesophageal reflux, those who require long-term enteral feeding in a non-hospital environment, and those who can support their caloric requirements with a self-administered enteral diet. Nasoenteric feeding tubes may also cause complications from either tube placement or enteral feeding. Complications resulting from a nasoenteric feeding tube placement include cribriform plate injuries, nasotracheal placement, alar cartilage erosion and tube occlusion which requires reinsertion of the tube. Complications resulting from enteral feeding include aspiration pneumonia, diarrhea, dehydration, and hyperglycemia.

Alternatively, a feeding tube may be placed surgically. In general, surgery involves providing an access to the stomach, inserting the feeding tube into the stomach, and securing the inserted feeding tube to the abdominal wall. Although surgical gastrostomy or jejunostomy allows accurate placement of the feeding tube, a surgical procedure is invasive, costly, and may be inappropriate for certain patients. In addition, surgery can cause complications such as bleeding, infection, pneumonia, myocardial injuries, and even death.

Still another way to place a feeding tube in a patient is to place it percutaneously or laparoscopically. Percutaneous and laparoscopic methods, however, are not widely utilized due to fear of blindly puncturing the abdomen. Percutaneous endoscopic gastrostomy overcomes this problem, but requires endoscopy which is uncomfortable for a patient. Several percutaneous endoscopic gastrostomy techniques exist including the pull technique, the push technique, and the introducer technique.

According to the pull technique, an endoscope is inserted into a patient's mouth and passed through the esophagus into the stomach. The patient's stomach is insufflated, and an opening to the stomach is made by inserting a needle into the stomach. An introducer catheter is introduced into the stomach through the opening. A guide wire is introduced into the stomach through the introducer, and an endoscopic snare tightens around the guide wire. The endoscope, the snare, and the guide wire are pulled out of the patient's mouth. A feeding tube is attached to an end of the guide wire extending from the mouth, and the guide wire extending from the stomach is pulled. This motion pulls the feeding tube through the esophagus and the stomach and positions the feeding tube such that the end of the feeding tube with the retention device remains inside the stomach, while the rest of the feeding tube remains outside the stomach.

The push technique is similar to the pull technique, except that the feeding tube is pushed through the abdominal wall over the guide wire, rather than being attached and pulled into the stomach. The guide wire is placed inside the patient in the same manner as in the pull method.

The introducer technique differs from the push and pull techniques in that the feeding tube is inserted through the abdominal wall and not through the mouth. After an endoscope is advanced into the stomach, a T-fastener is placed to move the stomach close to the abdominal wall. A needle is inserted through the abdominal wall into the stomach to create an opening. A guide wire is advanced through the opening, and an introducer with a peel-away sheath is passed over the guide wire. The introducer is then removed, and a gastrostomy tube is inserted into the stomach through the peel-away sheath. The feeding tube is a catheter with a Foley balloon at its distal end. The balloon is inflated to retain the feeding tube inside the stomach. The sheath is then peeled away, leaving behind the feeding tube.

Since proper feeding tube placement in a jejunum is more difficult than placing the feeding tube in a stomach, a jejunostomy tube is typically placed through a gastrostomy tube already positioned in a patient. A jejunostomy tube is typically longer and has a smaller cross section than a gastrostomy tube. Existing jejunostomy method, however, requires the use of an endoscope to provide visualization while feeding the tube through a duodenum into a jejunum. A guide wire is inserted through the gastrostomy tube and the jejunostomy tube is advanced over the guide wire into a jejunum under endoscopic guidance.

With existing feeding tube placement methods, feeding tube placement in a patient can be an unpleasant experience. However many patients must also go through feeding tube replacement. Approximately 70% of all patients receiving gastrostomy or jejunostomy feeding need long term feeding, which requires replacement of the feeding tube on a regular basis. During gastrostomy tube replacement, it is critical that the replacement tube is properly placed within the gastric cavity, and not into peritoneal space. Existing replacement method involves removing the tube in place and simply inserting the replacement tube into the gastric cavity through an existing opening. Physicians must endoscope the patient during this replacement procedure or send the patient to radiology to confirm proper tube replacement. Therefore, accurate feeding tube replacement can be invasive and burdensome to the patient. A feeding tube that is capable of accurate placement and replacement with minimal invasiveness to the patient would be useful.

SUMMARY OF THE INVENTION

The invention relates to an optical feeding tube. The optical feeding tube permits visualization of a passageway ahead of a distal end of the feeding tube, while the feeding tube is being placed in a patient, thereby eliminating the need for endoscopy. The optical feeding tube performs ideally as replacement feeding tubes. The optical feeding tube, however, may also be used for initial feeding tube placement when used according to the introducer method.

In general, in one aspect, the invention features an optical feeding tube which includes an elongated sheath having a first lumen for delivering nutrients to a gastro-intestinal tract and a second lumen. An imaging device is disposed in the second lumen. The imaging device provides visualization of an area adjacent a distal end of the elongated sheath.

Embodiments of this aspect of the invention include the following features. In some embodiments, the imaging device comprises an optical fiber extending from a proximal end to a distal end of the elongated sheath. In other embodiments, the optical feeding tube further includes a retention device disposed at a distal end of the elongated sheath. The retention device prevents movement of the feeding tube after placement. One example of the retention device is a balloon. In this embodiment, the elongated sheath includes a third lumen for transporting a fluid to and from the balloon. Another example of the retention device is a bolster.

In general, in another aspect, the invention features a method for placing a feeding tube inside a gastro-intestinal tract. According to the method, a distal end of the feeding tube is inserted into an opening which extends through an abdominal wall into a stomach cavity. The feeding tube includes an elongated sheath having a first lumen for delivering nutrients and a second lumen. An imaging device is disposed in the second lumen. The feeding tube is passed through the opening into the gastrointestinal tract under observation. A passageway ahead of a distal end of the feeding tube can be observed by looking into a proximal end of the imaging device. The distal end of the feeding tube is positioned at a desired location within the gastro-intestinal tract. In one example, the distal end of the feeding tube is placed in a stomach cavity. In another example, the distal end of the feeding tube is placed in a jejunum. In some embodiments, the method further includes the following additional steps. Initially, an opening which extends through the abdominal wall into the stomach cavity is made. A guide wire is advanced through the opening. An introducer with a sheath is passed over the guide wire. The feeding tube is inserted through the sheath.

The foregoing and other objects, aspects, features, and advantages of the invention will become more apparent from the following description and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention.

FIG. 1A is a plan view of an optical feeding tube having a balloon retention device.

FIG. 1B is a cross section view of the optical feeding tube of FIG. 1A taken alongline1B′-1B″.

FIG. 2A is a plan view of an optical feeding tube having a bolster retention device.

FIG. 2B is a cross section view of the optical feeding tube of FIG. 2A taken alongline2B′-2B″.

FIG. 3 is a plan view of a deflectable optical feeding tube.

FIG. 4A is a plan view of an optical feeding tube.

FIG. 4B is a cross section view of the optical feeding tube of FIG. 4A taken alongline4B′-4B″.

FIG. 5A is a plan view of a stylet with a push pull deflectable handle.

FIG. 5B is a cross section view of the stylet of FIG. 5A taken alongline5B′-5B″.

FIG. 6A is a plan view of the optical feeding tube of FIG. 4A having the stylet of FIG. 5A inserted through the feeding lumen.

FIG. 6B is a cross section view of the optical feeding tube of FIG. 6A taken along6B′-6B″.

FIG. 7 is a plan view of another deflectable optical feeding tube.

FIG. 8A is a plan view of an optical feeding tube.

FIG. 8B is a cross section view of the optical feeding tube of FIG. 8A taken alongline8B′-8B″.

FIG. 9A is a plan view of a stylet deflectable in two directions.

FIG. 9B is a cross section view of the stylet of FIG. 9A taken alongline9B′-9B″.

FIG. 10A is a plan view of the optical feeding tube of FIG. 8A having the stylet of FIG. 9A inserted through the feeding lumen.

FIG. 10B is a cross section view of the optical feeding tube of FIG. 10A taken alongline10B′-10B″.

DESCRIPTION

Referring to FIGS. 1A and 1B, anoptical feeding tube10 includes anelongated sheath14 havingseveral lumens18,22,26 andports50,52,46 corresponding to eachlumen18,22,26 respectively. Thelumens18,22,26 extend from adistal end16 of theelongated sheath14 to aproximal end15 of theelongated sheath14, and eachlumen18,22,26 meets with its correspondingport50,52,46 at theproximal end15 of theelongated sheath14. Theelongated sheath14 is constructed from a standard catheter material which renders it flexible enough to be inserted through a gastrointestinal tract. Theelongated sheath14, for example, may be constructed from silicone, a family of urethanes including polyurethane, Tecoflex® manufactured by Thermedics (Woburn, Mass.), Percuflex™ manufactured by Boston Scientific Corporation (Natick, Mass.), and Flexima™ mmanufactured by Boston Scientific Corporation (Natick, Mass.). Theelongated sheath14 and theports50,52,46 may be constructed as a single piece by a single material. The first lumen is afeeding lumen18, which has a larger cross section area than theother lumens22,26. The feeding lumen receives nutrients at the feedingport50 and delivers the nutrients to a gastro-intestinal tract of a patient.

The second lumen is animaging lumen22 which houses animaging device23. Theimaging device23 provides visualization of a passageway ahead of the feedingtube10 while the feedingtube10 is being placed in a gastro-intestinal tract of a patient. More specifically, theimaging device23 provides visualization of an area adjacent thedistal end16 of theelongated sheath14. Theimaging device23, for example, may comprise a bundle of optical fibers, extending from theproximal end15 to thedistal end16 of theelongated sheath14 and a lens in communication with the optical fibers disposed at thedistal end16. The optical fibers, for example, may be coextruded in the second lumen. Theimaging device port52 includes a coupler (not shown) to which ahandle42 connects. Thehandle42 includes aneye piece41 and alight source connector43 to which an external light source (not shown) connects. The external light source provide visualization by transmitting light through the imaging device and illuminating an area near thedistal end16 of theelongated sheath14. A person placing the feedingtube10 can look into theeye piece41 and observe the illuminated gastro-intestinal tract of a patient, while placing the feedingtube10 inside the stomach cavity or the jejunum of the patient.

Theoptical feeding tube10 further includes a retention device (not shown) disposed at thedistal end16 of theelongated sheath14. In the embodiment of FIGS. 1A and 1B, the retention device is a balloon. Theelongated sheath14 includes a third lumen or afluid lumen26 through which fluid travels to and from the balloon to inflate and deflate the balloon. The balloon functions as a retention device when inflated. During thefeeding tube10 placement, the balloon remains deflated to facilitate insertion of the feedingtube10 through the abdominal wall. Once the feedingtube10 is properly positioned inside a gastro-intestinal tract, the balloon is inflated to prevent movement of the feedingtube10. More specifically the balloon prevents the feedingtube10 from sliding out of the stomach. Afluid port46 in communication with thefluid lumen26 at thedistal end15 of theelongated sheath14 receives fluid from an external fluid source (not shown).

Referring to FIGS. 2A and 2B, anoptical feeding tube54 includes anelongated sheath56 having afeeding lumen18 and animaging lumen22. A feedingport50 communicates with a proximal end of thefeeding lumen18. Animaging device port52 communicates with a proximal end of theimaging lumen22. A coupler (not shown) connects ahandle42 with theimaging device port52. Thehandle42 includes aneye piece41 and alight source connector43. Theelongated sheath56 has numbers from 1 to 9 displayed on its outer surface. These number assist in monitoring thefeeding tube54 movement, while the feedingtube54 is placed inside a patient.

Theelongated sheath54 further includes a bolster58 which functions as an internal retention device. Several types of bolsters are available for use with a feeding tube. For example, theoptical feeding tube54 may include a deformable bolster, a hollow sleeve surrounding and restricting the bolster and a rip-cord (not shown). While theoptical feeding tube54 is being inserted through the abdominal wall, the sleeve surrounding the bolster58 restrains its figure. Once thedistal end59 of the feedingtube54 is positioned inside the gastro-intestinal tract, the rip-cord is pulled and the sleeve is ripped, thereby exposing the full figure of the bolster58. The extended bolster58 has a cross section area larger than a cross section area of theelongated sheath56 and the opening through which thefeeding tube54 was inserted. The sleeve is removed and the bolster58 keeps the feedingtube54 from movement. Any bolster known to those skilled in this art may be used with theoptical feeding tube54. Theoptical feeding tube54 further includes anexternal retention device45. Theexternal retention device45 is slidably mounted on the body of theelongated sheath56 prior to the feedingtube54 placement. Once theoptical feeding tube54 is positioned, theexternal retention device45 is placed agains the abdomen, to further prevent movement of the feedingtube54.

Referring to FIG. 3, anoptical feeding tube62 is deflectable. A deflectable feeding tube facilitates its insertion through a gastro-intestinal tract. Theoptical feeding tube62 includes anelongated sheath64 having adeflectable tip66. Thetip66 deflects by deflecting astylet72 inserted in a feeding lumen of the feedingtube62. FIGS. 4A and 4B show anoptical feeding tube62 of FIG.3. Theoptical feeding tube62 includes anelongated sheath64 having afeeding lumen18 and animaging lumen22. Animaging device port52 has a coupler (not shown) at the proximal end for connecting ahandle42 to theport52. FIGS.5A and SB show adeflectable stylet72 insertable in thefeeding lumen18 of theoptical feeding tube62 of FIG.4A. Thestylet72 includes adeflecting wire74 and a deflectinghandle68. The deflecting handle68 operates in a push pull mode. The deflecting handle68 includes apiston member67 and areceptacle member69. As thepiston member67 pushes against thereceptacle member69, the deflectingwire74 deflects. Conversely, as thepiston member67 pulls away from thereceptacle member69, the deflectingwire74 straightens. Details of a push-pull deflection mechanism is well known to those skilled in the relevant art and do not constitute an inventive aspect. As illustrated in FIGS. 6A and 6B, the stylet of FIG. 5A is inserted and secured into thefeeding lumen18 of theoptical feeding tube62 of FIG.4A. Theoptical feeding tube62 is then inserted into a patient's gastro-intestinal tract. During the insertion, thetip66 may be deflected by adjusting relative positions between thepiston member67 and thereceptacle member69 of the deflectinghandle68. FIG. 6A shows the feedingtube62 in a straight position and FIG. 3 shows the feedingtube62 with thetip66 deflected. Once the feedingtube62 is positioned inside the gastro-intestinal tract, thestylet72 is removed and the feedingtube62 is ready to receive nutrients.

Referring to FIG. 7, theoptical feeding tube78 includes anelongated sheath74 and adeflectable tip82. Thetip82 is deflectable in two directions as shown byphantom lines83,84. Thetip82 is deflected by deflecting a stylet inserted in a feeding lumen of the feedingtube78. FIGS. 8A and 8B show theoptical feeding tube78 of FIG. 7 before a stylet is inserted into itsfeeding lumen18. Theoptical feeding tube78 is identical to theoptical feeding tube62 of FIGS. 4A and 4B. FIGS. 9A and 9B show astylet84. Thestylet84 includes two deflectingwires85 and a deflectinghandle86. Thestylet84 deflects in one direction when thehandle86 rotates clockwise and in the opposite direction when thehandle86 rotates counter-clockwise. This type of steering mechanism is well known to those skilled in the art and does not constitute an inventive aspect. In operation, thestylet84 is positioned inside thefeeding lumen18 of theoptical feeding tube78 prior to positioning theoptical feeding tube78 inside a gastro-intestinal tract of a patient. During the feeding tube placement, an operator controls deflection of thetip82 by rotating thehandle86. Rotation of thehandle86 causes distal ends of the deflectingwires85 to deflect, which in turn causes thedeflectable tip82 of the feedingtube78 to deflect. Once the feedingtube78 is properly positioned inside the gastro-intestinal tract, thestylet84 is removed. The feedingtube78 is then ready to receive nutrients.

The optical feeding tubes of the present invention may be used as both gastrostomy tubes and jejunostomy tubes. A difference between the two types of feeding tube is that a jejunostomy tube is typically longer and has a smaller cross-section area than a gastrostomy tube. A jejunostomy tube, for example, may have a cross-section diameter ranging from about 8 fr. to about 24 fr. A gastrostomy tube, for example, may have a cross-section diameter ranging from about 12 fr. to about 30 fr.

In one embodiment, an optical feeding tube of the present invention provides easy replacement of a gastrostomy tube, eliminating the need for an endoscopy or any other radiology procedures necessary to confirm proper tube placement. Once the existing feeding tube has been removed, a replacement feeding tube is simply inserted through an existing opening, which provides access to the stomach cavity through the abdominal wall. The operator inserts the replacement feeding tube under observation. The operator sees a passageway ahead of a distal end of the replacement feeding tube by looking into the eye piece. By visualizing the process, the operator can avoid placing the replacement feeding tube into a peritoneal space, which can injure the patient. Once the replacement feeding tube is properly placed inside the stomach cavity, an internal retention device is activated to hold the replacement feeding tube in place. An external retention device may also be placed against the abdomen to further prevent the replacement feeding tube movement.

In another embodiment, an optical feeding tube of the present invention is used as an initial gastrostomy tube. According to this embodiment, an opening which provides access to the stomach through the abdominal wall is first created. The opening, for example, may be created by inserting a needle through a patient's abdomen into his or her stomach cavity. A guidewire is advanced through the opening and an introducer with a peel-away sheath is passed over the guide wire. The introducer is then removed, and the optical feeding tube is inserted into the stomach through the sheath under observation. The sheath is then peeled away leaving behind the feeding tube. Unlike the existing introducer method, this method does not require an endoscope to confirm proper placement of the feeding tube.

In still another embodiment, the optical feeding tube is used as a jejunostomy tube. The jejunostomy tube, for example, is placed inside a gastro-intestinal tract through a regular gastrostomy tube already placed inside a patient. A regular gastrostomy tube does not have an imaging device. The jejunostomy tube is inserted into the feeding lumen of the regular gastrostomy tube. The jejunostomy tube is then inserted through a duodenum into a jejunum under visual guidance provided by the imaging device inside the jejunostomy tube. As a result, an endoscope is not required during the placement of the jejunostomy tube. The jejunostomy tube maybe inserted into a jejunum with an assistance of a guide wire. Alternatively, the jejunostomy tube having its own retention device may be placed inside a gastro-intestinal tract without the assistance of the gastrostromy tube.

Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention as claimed. Accordingly, the invention is to be defined not by the preceding illustrative description but instead by the spirit and scope of the following claims.

Claims (7)

What is claimed is:

1. A method for placing a feeding tube inside a gastro-intestinal tract, comprising:

(a) inserting a distal end of the feeding tube into an opening which extends through an abdominal wall into a stomach cavity, the feeding tube comprising an elongated sheath having a first lumen for delivering nutrients and a second lumen, and an imaging device disposed in the second lumen;

(b) passing the feeding tube through the opening into a gastro-intestinal tract while observing a passageway ahead of the feeding tube by looking into a proximal end of the imaging device; and

(c) positioning the distal end of the feeding tube at a desired location within the gastro-intestinal tract.

2. The method of claim1 further comprising activating a retention device to retain the feeding tube at the desired location.

3. The method of claim2 wherein activating the retention device comprises inflating a balloon disposed at the distal end of the elongated sheath.

4. The method of claim1 wherein step (c) comprises positioning the distal end of the feeding tube in the stomach cavity.

5. The method of claim1 wherein step (c) comprises positioning the distal end of the feeding tube in a jejunum.

6. The method of claim1 wherein step (b) comprises deflecting the distal end of the feeding tube to accommodate a curvature of the gastrointestinal tract.

7. The method of claim1 further comprising:

making an opening through the abdominal wall into the stomach cavity;

advancing a guide wire through the opening;

passing an introducer with a sheath over the guide wire;

and wherein step (a) comprises inserting the feeding tube through the sheath.

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